Clinical Research Coordinators (Non-R.N.)

Job Summary
Clinical Research Coordinators (Non-R.N.) This position is patient-sensitive and must fulfill all associated vaccination requirements or be approved for an exemption prior to the first day of work. We protect our patients coworkers and community by requiring all patient-sensitive employees to be immunized according to CDC standards and hospital policy. Limited exemptions may be made for documented medical contraindications or religious beliefs that object to vaccinations. Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs) study protocols and applicable regulations. Implement processes and organize efforts within study team to achieve objectives coordinating research procedures study visits and follow-up care. Create and maintain tools and documentation to track study metrics providing updates to management. Conduct pre-study site qualification study initiation monitoring visits and close-out activities. Maintain source documents and report adverse events. Recruit screen enroll and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments outside organizations and government agencies. Work under the direction of the Primary Investigator (PI). This position is eligible for a hybrid schedule (telecommuting & in-office) after successful completion of probationary period and requires on-site in-person to perform several of the research duties. This is NOT a fully remote position. Learn more about the great benefits of working for University of Utah: The department may choose to hire at any of the below job levels and associated pay rates based on their business need and budget.

Responsibilities
Essential Functions Assesses protocol for clarity and subject safety reviews inclusion/exclusion criteria; clarifies concerns and questions with Principal Investigator and sponsor. Attends and participates in Investigator and staff meetings. Advises team regarding specific study assignments and timelines. Explains and obtains informed consent medical history and demographics; documents in source file and maintains with historical data status reports progress notes and subject log to help ensure subject safety. Determines length of visits and coordinates related facility and equipment availability. Reports and tracks adverse events (AE). Reports serious AEs to IRB and sponsor. Documents all protocol deviations reconciles test article accountability at study close out and prepares summary report for sponsor. Completes audits corrects CRFs relays CRFs to sponsor. Assists with negotiating contract budget and payment terms. Maintains documents as required by FDA guidelines. May maintain contact with IRB and prepare and submit IRB documents. May ensure proper collection processing and shipment of specimens. May perform functions required of the Clinical Research Assistant as necessary. Problem Solving Incumbents are responsible for coordinating the daily operations of their assigned research team coordinating the orderly and safe flow of the research project and maintaining adequate resources for the PI to accomplish their research objectives. Comments Work Environment and Level of Frequency that may be required Nearly Continuously: Office environment. Physical Requirements and Level of Frequency that may be required Nearly Continuously: Sitting hearing listening talking. Often: Repetitive hand motion (such as typing) walking. Seldom: Bending reaching overhead. The staff member must be able to demonstrate the knowledge and skills necessary to provide care appropriate to the age of the patients served on his or her assigned unit. The individual must demonstrate knowledge of the principles of life span growth and development and the ability to assess data regarding the patients status and provide care as described in the departments policies and procedures manual. Clinical Research Coordinator (Non-R.N.) II Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs) study protocols and applicable regulations. Implement processes and organize efforts within study team to achieve objectives coordinating research procedures study visits and follow-up care. Create and maintain tools and documentation to track study metrics providing updates to management. Conduct pre-study site qualification study initiation monitoring visits and close-out activities. Maintain source documents and report adverse events. Recruit screen enroll and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments outside organizations and government agencies. Works under the direction of the Primary Investigator (PI). Requires moderate skill set and proficiency in discipline. Conducts work assignments of increasing complexity under moderate supervision with some latitude for independent judgment. Requires a bachelors (or equivalency) 4 years or a masters (or equivalency) 2 years of directly related work experience. This is a Developing-Level position in the General Professional track. Job Code: PZ6512 Grade: P13 Expected Pay Range: $29913 to $68625 Clinical Research Coordinator (Non-R.N.) III Coordinate day-to-day clinical trial activities in adherence to Good Clinical Practices (GCPs) study protocols and applicable regulations. Implement processes and organize efforts within study team to achieve objectives coordinating research procedures study visits and follow-up care. Create and maintain tools and documentation to track study metrics providing updates to management. Conduct pre-study site qualification study initiation monitoring visits and close-out activities. Maintain source documents and report adverse events. Recruit screen enroll and obtain consent from study participants. Collect and maintain patient and laboratory data. Work directly with study participants and families and serve as project liaison to other departments outside organizations and government agencies. Works under the direction of the Primary Investigator (PI). Considered highly skilled and proficient in discipline. Conducts complex important work under minimal supervision and with wide latitude for independent judgment. Requires a bachelors (or equivalency) 6 years or a masters (or equivalency) 4 years of directly related work experience. This is a Career-Level position in the General Professional track. Job Code: PZ6513 Grade: P15 Expected Pay Range: $36196 to $83036

Minimum Qualifications
EQUIVALENCY STATEMENT : 1 year of higher education can be substituted for 1 year of directly related work experience (Example: bachelors degree 4 years of directly related work experience). Department may hire employee at one of the following job levels: Clinical Research Coordinator (Non-R.N.) II: Requires a bachelors (or equivalency) 4 years or a masters (or equivalency) 2 years of directly related work experience. Clinical Research Coordinator (Non-R.N.) III : Requires a bachelors (or equivalency) 6 years or a masters (or equivalency) 4 years of directly related work experience.